Device Recall SmartSite

Lot No. 12056016, 12057027, and 12107105.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

SmartSite Low Sorbing Infusion Set, Model No. 10015862 || The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

15055146 15055702 15056299 15056618 15065645 15075740 15076166 15076167 15076664 15076729 15077085 15085031 15085156 15086107 15095014 15095411 15106928 15116928 15125952 15126069 15127413 16015324 16015325 16015607 16025824 16025948 16027008 16035527 16036131

General Hospital and Personal Use Devices

2

No

US Distribution

SmartSite Add-On Bag Access Device, Model No. 10013365

Lot Number 13016314

General Hospital and Personal Use Devices

2

No

CA, FL, AZ, and TN

SmartSite Low Sorbing Infusion Set, Model#72313E || The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.

Lot No:  13046215 13046641 13056285 13056577 13075931

General Hospital and Personal Use Devices

2

No

US Distribution in CA, WY, OH, UT, and MA.

SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T || The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

Lot Numbers:  13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.

SmartSite Needleless Connector, Model No. 2000E || The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.